Patent Term Adjustments and Extensions: Leveraging Recent Decisions and USPTO Rules

A live 90-minute CLE webinar with interactive Q&A

Thursday, October 12, 2017
1:00pm-2:30pm EDT, 10:00am-11:30am PDT

Early Registration Discount Deadline, Friday, September 22, 2017

This CLE webinar will provide guidance to IP counsel for calculating patent term adjustments, interplay with patent term extensions, examine recent court treatment, and offer approaches for preserving rights and maximizing patent term adjustments and patent term extensions.


After the Federal Circuit’s decision in Novartis v. Kappos (2014) holding that filing an RCE stops the accumulation of B-delay, the USPTO implemented PTA rule changes in January 2015: “Changes to Patent Term Adjustment in View of the Federal Circuit Decision in Novartis v. Lee.”

Since then, the Federal Circuit decided Gilead Sciences Inc. v. Lee (2015), Mohsenzadeh v. Lee (2015), and Daiichi Sankyo Co. Ltd. v. Lee (2015). In Gilead, the Federal Circuit upheld the USPTO’s PTA calculation that subtracted days between Gilead filing a response to a restriction requirement and a supplemental IDS.

In Mohsenzadeh, the Federal Circuit addressed A-delay, holding that a patent is only entitled to PTA for delay in the prosecution of the application from which the patent directly issued, not the application from which it derived priority. In Daiichi, the Federal Circuit again decided in favor of the USPTO with regards to the “Interim Procedure” instituted post-Wyeth.

We now have district court decisions, such as Supernus Pharms. Inc. and United Therapeutics v. Lee, Case No. 1:16-cv-00342 (E.D. Va. Oct. 18, 2016), appeal pending, challenging the USPTO’s application of its rules and Gilead in its PTA calculations. The impact of prosecution actions on eventual PTA remains an important aspect of practitioners’ considerations as the case law continues to evolve.

Patent term extensions under 35 U.S.C. 156 were designed to create new incentives for research and development of certain products subject to pre-market government approval by a regulatory agency. The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to the terms of those patents some of the time lost while awaiting pre-market government approval from a regulatory agency.

These extensions can be very important for certain products, particularly pharmaceutical products. There is little room for error in these applications, as a denied application can mean the loss of millions to billions of dollars. Familiarity with the statute, governing rules and legal precedent is thus crucial.

Listen as our authoritative panel of patent attorneys examines the recent developments for PTAs and their potential impact, methods for calculating PTA, what can be done to preserve rights, and offers best practices for maximizing PTA. Also included in the discussion will be patent term extension considerations.


  1. Recent case law developments
  2. Calculating PTA
    1. 14-4-4-4
    2. Wyeth 3 yr. pendency
    3. RCE and terminal disclaimer impact
  3. Patent term extensions
    1. Eligibility
    2. Calculation
    3. Restrictions on PTE
  4. Best practices
    1. Preservation of rights
    2. Maximizing PTA vs. PTE


The panel will review these and other key issues:

  • What are the lessons from the recent Federal Circuit decisions regarding the patent term calculation?
  • How will the recent changes for the USPTO alter the landscape for PTA and PTE practice?
  • What best practices should patent applicants take to preserve rights and maximize PTA and PTE?


Thomas L. Irving, Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.

Jill K. MacAlpine, Ph.D., Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling, primarily in the chemical and pharmaceutical areas. She has extensive experience in handling patent matters before the U.S. Patent and Trademark Office (USPTO), including post-grant proceedings specifically IPRs, appeals, and oral hearings at the PTAB; drafting and prosecution of patent applications; reissue and reexamination proceedings; and interferences.

Charles E. Van Horn, Senior Counsel
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Mr. Van Horn has a strong working knowledge of the specialized areas of patent reexamination, patent term extension, and procedures under the Patent Cooperation Treaty. After a 31-year career at the USPTO, he joined the firm and has served in a variety of leadership positions relating to patent policy and practice. While deputy solicitor, he argued cases in the federal courts. As deputy assistant commissioner, he established the policy and practice for examining patent applications.

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Customer Reviews

The webinar gave us a timely, up-to-date review of PTAs and PTEs, incorporating review of new PTO rules and recent court cases.

Verne A. Luckow

This was the first time our firm participated in a Strafford Webinar and it was very successful.

Cynthia Leonard

Birch, Stewart, Kolasch and Birch

The presentations of the timelines by each speaker were especially valuable! This was an excellent introduction to Strafford's offerings!

Donna Johnson Gressler

The slides were very clear and informative. The lecturers provided a lucid explanation of the materials. Indeed, they were very knowledgeable of the subject matter and advised of the latest developments in the area, including the latest relevant court decisions and the latest rules and proposed rules from the USPTO.

Mark J. Cohen

Scully Scott Murphy & Presser

The webinar provided insightful analysis of the complicated issues that related to the material.

Gerald Worth

Proskauer Rose

or call 1-800-926-7926

Patent Law Advisory Board

Charles S. Baker


Locke Lord

David S. Bloch


Winston & Strawn

Irah H. Donner



Ian N. Feinberg


Feinberg Day Alberti & Thompson

Anthony J. Fitzpatrick


Duane Morris

David Segal

Senior IP Counsel


Astrid R. Spain


Jones Day

Mark P. Wine



or call 1-800-926-7926

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